Zasocitinib

OSAKA, Japan and CAMBRIDGE, Massachusetts, March 25, 2026 – Takeda (TSE:4502/NYSE:TAK) announced today its Board of Directors approved the next steps in the Company's transformation to strengthen competitiveness, enhance its long-term growth profile and accelerate launch execution in the years ahead. The transformation, aligned with the previously announced organizational structure, is expected to deliver annualized gross savings of more than JPY 200 billion by FY2028, positioning the company for its next era. Increased efficiencies from the transformation will be achieved through streamlining of corporate functions, bringing leadership and teams closer to patients and customers and process simplification made possible by advanced technologies. These efficiencies will largely offset investments needed to prepare for multiple launches, including oveporexton, rusfertide and zasocitinib, progress the late-stage pipeline and support strategic technology investments. “Today, Takeda is setting the stage to make a greater impact on the lives of patients as we prepare to launch multiple new medicines and continue to deliver on the promise of our pipeline,” said Julie Kim, CEO-Elect, Takeda. “The deliberate steps we are taking will strengthen our ability to execute with speed while strategically prioritizing resources and positioning ourselves for long-term growth and success in the next era.” As a result of these initiatives, Takeda currently estimates it will incur restructuring expenses of approximately JPY 150 billion in FY2026, with lower restructuring expenses also anticipated in FY2027 and FY2028. The FY2026 restructuring expenses will be reflected in the Company’s consolidated financial forecast for FY2026 to be announced in the FY2025 full-year earnings announcement. Details and timing of specific initiatives will be determined in due course. There is no significant impact on the full-year consolidated financial forecast for FY2025 from these initiatives. Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com. Christopher O’ReillyChristopher.oreilly@takeda.com+81 (0) 90-6481-3412 Media_Relations@takeda.com For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners. This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

谁能想到？当年横扫血液肿瘤的“抗癌顶流”BTK抑制剂，2026年直接在炎症性皮肤病领域“杀疯了”！ 2026年3月24日，全球首个慢性自发性荨麻疹（CSU）口服靶向药——瑞米布替尼（商品名：瑞普多®）全国首张处方正式落地！从FDA获批到国内首方开出，仅半年时间，BTK抑制剂彻底改写皮肤科治疗版图，堪称医学圈年度“王炸”事件！ 今天咱们就用轻松又专业的方式，扒一扒这款“跨界神药”的封神之路，还有未来更让人期待的“神仙打架”管线！ 一、CSU患者的“救命药”来了！瑞米布替尼凭什么一战封神？ 先问个扎心的问题：慢性自发性荨麻疹（CSU）有多折磨人？反复起风团、瘙痒到半夜睡不着，出门怕风吹怕日晒，H1抗组胺药吃了无数却毫无效果，长期被“痒”和“怕复发”支配，这就是无数CSU患者的日常。 而瑞米布替尼的出现，直接打破了这个死局！ ✅ 身份硬核：全球首个获批CSU的BTK抑制剂，专门针对H1抗组胺药无效/不耐受的成人患者，国产患者终于不用再等进口药！✅ 起效超快：Ⅲ期临床数据显示，用药2周就能快速控症，风团瘙痒明显消退；12周约1/3患者实现完全缓解，52周长期吃，疗效稳稳不衰减！✅ 用药省心：口服每日2次，不用天天跑医院监测实验室指标，对打工人、宝妈们太友好了！ 它的核心原理超简单：BTK是皮肤炎症的“总开关”，瑞米布替尼精准“掐断”开关，从源头阻止肥大细胞、嗜碱性粒细胞释放组胺等“致痒致肿”物质，真正做到源头控症，而非被动止痒！ 图1 瑞米布替尼作用机制示意图图示说明：左侧为肥大细胞FcεRI信号通路，IgE交联受体后经Lyn-Syk-BTK-PLCγ2级联激活，触发Ca²⁺内流与颗粒释放，介导风团、瘙痒与血管扩张；右侧为瑞米布替尼作用靶点，药物共价结合BTK活性口袋，阻断下游信号传导，同时抑制B细胞活化与自身抗体产生，实现免疫稳态调控。图例：→ 信号激活；⊣ 药物抑制；⊕ 细胞脱颗粒与炎症介质释放。 二、已上市BTKi“全员搞副业”！国产+进口，皮肤科赛道内卷出圈 除了瑞米布替尼，咱们熟悉的BTK抑制剂们也没闲着，纷纷“跨界”皮肤科，国产药企更是领跑全场！ 简单说：国产药抢着做“差异化创新”，进口药稳扎稳打攻“难治重症”，不管是化脓性汗腺炎还是天疱疮，都有了新盼头！ 三、在研管线大爆料！2026-2027，这些BTK新药更“能打”！ BTK抑制剂的潜力远不止现在这些，未来1-2年的研发管线直接让人热血沸腾，每一款都直击痛点！ 1. 专治耐药的“狠角色” - BGB-16673（百济神州）：全球首款BTK降解剂！不只是“抑制”活性，而是直接“降解”BTK蛋白，彻底解决C481S耐药突变。2026年上半年就出Ⅰ期数据，专治“吃药没用”的难治患者！- SH2结构域抑制剂（Recludix）：全新机制！不按常规套路出牌，精准靶向BTK的“特殊部位”，选择性拉满，几乎没有脱靶副作用，临床前模型对CSU效果超棒，2026年正式进临床试验！ 2. 适应症“全覆盖”，难治皮肤病全有救 - 瑞扎布鲁替尼（赛诺菲）：瞄准天疱疮Ⅲ期，和吡托布鲁替尼“正面刚”，给自身免疫大疱病患者多一个选择；- 瑞米布替尼（诺华）：冲刺化脓性汗腺炎Ⅲ期，探索BTK抑制剂在“慢性炎症重灾区”的长期效果；- Zasocitinib（武田）：补位化脓性汗腺炎Ⅱ期，让HS的治疗方案更丰富！ 四、2026最新突破！BTK在皮肤科的“隐藏技能”被解锁 今年的研究更是让BTK抑制剂的地位“坐实”了： 1. 双重打击机制：中性粒细胞里的BTK，通过FcγR-BTK-LTB4轴引爆类天疱疮炎症。这意味着BTK抑制剂能同时“打B细胞（产抗体）”和“打中性粒细胞（引炎症）”，双管齐下更高效！2. 外用剂型新方向：伊布替尼做成乳膏、凝胶，外用涂天疱疮模型就有效！以后轻中度患者不用口服，局部用药就能治，副作用直接减半！ 五、小吐槽+大展望：BTK抑制剂的“未来可期” 当然，它也不是完美的：长期吃可能有感染、出血风险，不同皮肤病该怎么选药也需要进一步明确。但这些小问题，挡不住它的发展势头！ 未来的皮肤科，BTK抑制剂绝对是“顶流”： - 联合治疗：和JAK抑制剂、生物制剂组队，难治性疾病缓解率直接拉满；- 剂型升级：外用、长效剂型陆续上线，吃药更轻松；- 国产领跑：降解剂、高选择性抑制剂陆续上市，国产药撑起皮肤科精准治疗半边天！ 【最后一句心里话】 2026年瑞米布替尼全国首方落地，不只是一款新药的上市，更是炎症性皮肤病从“传统治疗”到“精准靶向”的跨越！ 从CSU到天疱疮、HS、SLE，从进口到国产创新，BTK抑制剂正在用实力证明：它不仅是肿瘤界的“王牌”，更是皮肤科的“新支柱”。 未来3-5年，期待它能帮更多被难治性皮肤病折磨的患者，摆脱瘙痒、水疱、反复复发的烦恼，真正实现“无病无忧”的生活！   【互动时间】作为医学专业人士/患者家属，你对BTK抑制剂在皮肤科的应用最期待哪部分？是新药获批、国产创新还是外用剂型？欢迎在评论区聊聊！ 温馨提示：本文仅供医学领域参考，具体用药请遵医嘱，切勿自行尝试哦～